A Multicentre,Study of IBI133 in Subjects WithUnresectable, Locally Advanced or Metastatic SolidTumours

NCT ID: NCT06170190

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-16
• Study Completion Date: 2025-02-19

Brief Summary

This is a multicentre, open-label, first-in-human, phase 1/2 study of IBI133 in subjects with unresectable, locally advanced or metastatic solid tumours. Phase 1 section includes three parts, IBI133 dose escalation part, and IBI133 monotherapy dose expansion part. The objective of phase 1 section is to identify MTD/recommended dose for expansion (RDE) of IBI133 monotherapy . The objective of phase 2 section is to further explore efficacy, safety and tolerability of IBI133 monotherapy at RDE in specified tumour population. The treatment cycle of the study is defined as every 3 weeks (21 days).

Conditions

Locally Advanced Unresectable or Metastatic Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open-label：IBI133 monotherapy

Group Type: EXPERIMENTAL

IBI133

Intervention Type: BIOLOGICAL

IBI133:

The provisional dose levels are planned to be evaluated, but it is possible for additional and/or intermediate dose levels to be added during the course of the study. Q3W

Interventions

IBI133

IBI133:

The provisional dose levels are planned to be evaluated, but it is possible for additional and/or intermediate dose levels to be added during the course of the study. Q3W

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;

2. Male or female subjects ≥ 18 years old;

3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;

4. Anticipated life expectancy of ≥ 12 weeks;

5. Adequate bone marrow and organ function.

6. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumour that is refractory to or intolerable with standard treatment, or for which no standard treatment is available;

Exclusion Criteria

1. Participate in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of the interventional study;

2. Prior HER3 targeted treatment, including but not limited to monoclonal antibody, bispecific antibody, T cell engager, and antibody-drug conjugate.

3. Prior treatment with an antibody-drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g. DS-8201).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Liverpool Hospital

Liverpool, New South Wales, Australia

Countries

Australia

Other Identifiers

CIBI133A101

Identifier Type: -

Identifier Source: org_study_id